Early halt for successful apixaban trial
pharmafile | June 14, 2010 | News story | Research and Development | apixaban, atrial fibrilation
Pfizer and Bristol-Myers Squibb’s atrial fibrillation treatment apixaban has performed so well in a phase III trial that it has been halted early.
The AVERROES study showed clear evidence of a clinically important reduction in stroke and systemic embolism in patients with atrial fibrillation, who are considered intolerant of or unsuitable for vitamin K antagonist therapy who received apixaban as compared to aspirin.
AVERROES included 5,600 patients with patients randomised to receive either apixaban 5mg twice daily or aspirin 81mg to 324 mg once daily.
Pfizer and BMS began collaborating on the drug’s development in 2007 after apixaban had been originally developed by BMS.
If brought to market, the drug will be competing against Bayer/Johnson & Johnson’s Xarelto and Boehringer Ingelheim’s Pradaxa. It will also be competing against Sanofi-Aventis’ new AF treatment Multaq, which received a limited NICE approval in March.
The Xa inhibitor apixaban is being investigated within the EXPANSE clinical trials programme that is estimated to include nearly 60,000 patients worldwide across multiple indications and patient populations and includes a total of nine completed or ongoing, randomised, double-blind phase III trials, including AVERROES.
The apixaban phase III trial programme is evaluating the prevention of VTE, prevention of stroke and other thromboembolic events in patients with AF, the treatment of venous thromboembolism and secondary prevention of cardiovascular events in patients with acute coronary syndrome.
Ben Adams
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